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NCT00535054 Clinical Trial

Study to Assess the Safety and Patients' Satisfaction of Tears Again* in the Treatment of Dry Eye Symptoms

Dry Eye Syndrome Clinical Trial

Official title:
An Open Study to Assess the Safety and Patients' Satisfaction Tears Again* in the Treatment of Dry Eye Symptoms

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00535054
Other study ID # 06.11
Secondary ID
Status Completed
Phase N/A
First received September 23, 2007
Last updated February 7, 2010
Start date September 2007
Est. completion date February 2010

Study information
Verified date February 2010
Source Trima, Israel Pharmaceutical Products
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine safety and patients' satisfaction when using Tears Again to treat Dry Eye Symptoms.

Recruitment information / eligibility
Status Completed
Enrollment 125
Est. completion date February 2010
Est. primary completion date February 2010
Accepts healthy volunteers No
Gender Both
Age group 25 Years to 85 Years
Eligibility Inclusion Criteria:

- Suffer from at least two of the following ocular symptoms: burning, stinging, excessive tearing, dryness, grittiness, foreign body sensation ( including patients suffering from blepharitis).

- Use artificial tears or any other treatment for these symptoms three or more times a day.

Exclusion Criteria:

- Known hypersensitivity to Phenoxyethanol.

- Pregnant and lactating women.

- Receive other ophthalmic medication (except for eyelid hygiene preparations).

- Graft-versus-host disease patients.

- Participated during the last month in another clinical trial.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Tears Again
Liposome Eye Spray

Locations
Country Name City State
Israel Department of Ophthalmology, Assaf Harofeh Medical Center, Zerifin

Sponsors (1)
Lead Sponsor Collaborator
Trima, Israel Pharmaceutical Products

Country where clinical trial is conducted

Israel, 

References & Publications (2)

Dausch D, Lee S, Dausch S, Kim JC, Schwert G, Michelson W. [Comparative study of treatment of the dry eye syndrome due to disturbances of the tear film lipid layer with lipid-containing tear substitutes]. Klin Monbl Augenheilkd. 2006 Dec;223(12):974-83. German. — View Citation

Lee S, Dausch S, Maierhofer G, Dausch D. [A new therapy concept for the treatment of dry eye--the usefulness of phospholipid liposomes]. Klin Monbl Augenheilkd. 2004 Oct;221(10):825-36. German. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Schirmer Test, Lissamine Green Test and BUT. On enrollment and one month later. No
Secondary Questionaire One, three and four weeks after treatment commencement. Yes
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